Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, August 2016.
In July 2015 the US FDA (Food and Drug Administration) approved sonidegib (Odomzo®; Novartis, New Jersey, USA) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC).
The European Commission approved the use of sonidegib for basal cell carcinoma in August 2015. In June 2016, sonidegib was granted marketing authorisation in Switzerland for treatment of adults with advanced basal cell carcinoma. The drug is also approved in Australia. Additional regulatory submissions are being reviewed by health authorities worldwide.
Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
The most common (≥ 10%) adverse reactions associated with sonidegib treatment in clinical trials were:
The safety and effectiveness of sonidegib has not been established in children (<18 years of age).
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